Associations between patient-level health literacy and diagnostic time intervals for head and neck cancer: A prospective cohort study.

BACKGROUND: Health literacy (HL) comprises skills and knowledge required to understand, access, and make decisions about healthcare. Our aim was to examine associations between patient HL and time intervals (defined in the Aarhus statement) along the pathway to treatment of head and neck cancer (HNC). METHODS: A prospective cohort study was conducted from October 2018 to March 2020. Participants completed the Health Literacy Questionnaire (HLQ®) and described key events and dates along the pathway to treatment using validated questionnaires. Correlations between six diagnostic time intervals and domains of HL were explored, and factors predicting exceeding maximum acceptable timeframes were assessed using logistic regression. RESULTS: One hundred patients with a diagnosis of HNC within the preceding 6 months were recruited. HLQ® Domain 2 (sufficient information to manage health) was significantly negatively associated with four intervals: the patient interval (first symptom to first presentation), primary care interval (first presentation to referral to secondary care), diagnostic interval (first presentation to diagnosis), and total interval (first symptom to treatment onset); correlation coefficients -0.25 to -0.27 (P < 0.05). Domain 8 (ability to find good information) was significantly negatively associated with three intervals (primary care interval, diagnostic interval, and total interval; correlation coefficients -0.23 to -0.34; P < 0.05). Higher education, age, and comorbidity levels were associated with shorter patient and diagnostic intervals. CONCLUSIONS: HL may be a potential target to improve timeliness of HNC diagnosis and reduce disparities in outcomes.

A 10-year update to the principles for clinical trial data sharing by pharmaceutical companies: perspectives based on a decade of literature and policies.

Data sharing is essential for promoting scientific discoveries and informed decision-making in clinical practice. In 2013, PhRMA/EFPIA recognised the importance of data sharing and supported initiatives to enhance clinical trial data transparency and promote scientific advancements. However, despite these commitments, recent investigations indicate significant scope for improvements in data sharing by the pharmaceutical industry. Drawing on a decade of literature and policy developments, this article presents perspectives from a multidisciplinary team of researchers, clinicians, and consumers. The focus is on policy and process updates to the PhRMA/EFPIA 2013 data sharing commitments, aiming to enhance the sharing and accessibility of participant-level data, clinical study reports, protocols, statistical analysis plans, lay summaries, and result publications from pharmaceutical industry-sponsored trials. The proposed updates provide clear recommendations regarding which data should be shared, when it should be shared, and under what conditions. The suggested improvements aim to develop a data sharing ecosystem that supports science and patient-centred care. Good data sharing principles require resources, time, and commitment. Notwithstanding these challenges, enhancing data sharing is necessary for efficient resource utilization, increased scientific collaboration, and better decision-making for patients and healthcare professionals.

Patient-reported experiences and satisfaction with head and neck surgery outreach clinics in regional New South Wales, Australia: A cross-sectional survey.

RATIONALE: Head and neck surgery services are increasingly being centralised in Australia. Outreach models can overcome burdens of travel that patients in regional and rural areas experience when attending routine appointments, by providing services closer to home. AIM: To explore patient-reported experiences and satisfaction with regional outreach services for head and neck surgery in Australia. METHODS: Patients who attended two regional outreach clinics in New South Wales (NSW), Australia, were surveyed over a 6-month period. Patients completed the Outpatient Cancer Clinics Survey (2020 version) that explored perceptions and experiences of the clinic. Patients with cancer were asked to complete the Edmonton Symptom Assessment System and the Communication and Attitudinal Self-Efficacy scale. Descriptive statistics and analysis of data was performed, and results were compared to the NSW statewide Outpatient Cancer Clinics Survey (2020). Content analysis of free text responses was performed. RESULTS: Some 128 patients responded (56% response rate; mean age 67.2 years, 46.1% female). Compared to the 2020 NSW survey, a higher proportion of patients in our cohort responded positively to 14 of the 26 questions, with the greatest differences observed for questions regarding waiting area comfort (+12.1%, p = 0.008), being informed about different treatment options (+9.5%, p = 0.04), and issues relating to parking (+9.5%, p = 0.03). A lower proportion of our sample responded positively to the question about whether health professionals knew enough about their medical history (-19.3%, p < 0.001). Respondents appreciated having a local clinic that helped them avoid travel to major cities and associated expenses and highlighted benefits of expert consultation and timeliness of investigations. However, cost of appointments and level of reimbursements remain barriers for some patients. CONCLUSIONS: Patients had a high level of satisfaction with regional outreach clinics for head and neck surgery across most domains, indicating patients highly value this service.

Travel-associated cost savings to patients and the health system through provision of specialist head and neck surgery outreach clinics in rural New South Wales, Australia.

INTRODUCTION: Centralisation of head and neck surgical services means that patients in regional and remote Australia need to travel long distances for treatment and follow-up, imparting a significant financial burden on patients and the health system. OBJECTIVE: To estimate costs of travel to local outreach clinics and determine potential cost savings to patients and the health system by avoiding patient travel to major cities for head and neck surgical care. DESIGN: Retrospective audit of three head and neck surgery outreach clinics in New South Wales, Australia over 4 years (2017-2020). Direct costs of travel from a patient's residence to their local outreach clinic were estimated. Costs of travel and accommodation to Sydney for an appointment were calculated for different travel modes. Estimated reimbursements for travel through government support schemes were calculated based on published rates. FINDINGS: Some 657 patients attended the three clinics, accounting for 1981 appointments. Depending on mode of travel, the estimated median cost of return travel (including accommodation) to Sydney was $379 to $739 per patient per trip and the median government reimbursement ranged from $182 to $279 per trip. In comparison, the cost of return travel by car to local outreach clinics ranged from $28 to $163 per appointment. Outreach clinics were estimated to save patients a median of $285 per trip and avoided government reimbursements of $215 per trip. DISCUSSION: Despite uptake in telehealth, outreach medical services remain an important asset for people living in regional areas to address inequities in access. However, the cost benefits are likely to be underestimated as our approach did not account for indirect costs associated with travel. CONCLUSION: Outreach head and neck surgical services located in regional areas can reduce the financial burden on both patients and the healthcare system. Greater investment in outreach clinics could ensure sustainability of services to promote equitable access to specialised surgical services.

Construct and discriminant validity testing of the FACE-Q Head and Neck Cancer Module for assessing speech and swallowing outcomes for patients undergoing maxillectomy or mandibulectomy.

BACKGROUND: The FACE-Q H&N is a patient reported outcome measure covering multiple constructs for patients with head and neck tumors. Additional testing is needed to determine suitability in assessing speech- and swallowing-related quality of life and function. METHODS: FACE-Q H&N, The M. D. Anderson Dysphagia Inventory (MDADI), and Speech Handicap Index (SHI) scores were collected from two patient cohorts who had undergone jaw reconstruction. Construct validity was assessed using convergent validity testing and known groups testing to assess discriminant validity. RESULTS: A priori hypotheses testing demonstrated strong correlations (ρ > 0.6, p < 0.05) between FACE-Q H&N eating and drinking, swallowing and eating distress scales with MDADI subscales, and between FACE-Q H&N speech function and distress scales and the SHI. Known groups testing demonstrated all instruments could delineate outcomes among patients who had radiation, advanced tumors, and tracheostomy. CONCLUSION: The FACE-Q H&N may be an alternative for the SHI and MDADI in this patient cohort.

Interventions to reduce times to diagnosis and treatment of head and neck cancer: A systematic review and narrative synthesis.

BACKGROUND: We systematically reviewed evidence of health system interventions to reduce diagnostic and treatment intervals for people with head and neck cancer (HNC). METHODS: Electronic databases were searched from inception to 30 April 2020 for controlled or uncontrolled comparative studies. Primary outcome was any time interval between first clinical presentation and treatment onset. RESULTS: Thirty-seven studies were included. Four types of interventions were identified: single clinic-based (N = 4), multidisciplinary clinic-based (N = 15), hospital or service re-design (N = 12), and health system re-design (N = 6). There was some evidence that multidisciplinary interventions improve timeliness of diagnosis and treatment; however, evidence of long-term effectiveness was lacking. Study quality was assessed as either low or moderate. CONCLUSIONS: Interventions to reduce times to diagnosis and treatment of HNC are heterogeneous, with limited evidence of effectiveness. Future interventions should account for the complex and dynamic nature of health systems and adhere to best-practice principles for early-diagnosis research.

Effect of Radiotherapy on Functional and Health-Related Quality of Life Outcomes after Jaw Reconstruction.

Long-term health-related quality of life (HRQOL) and functional outcomes following mandibular and maxillary reconstruction are lacking. To determine these outcomes, a cross-sectional study of patients with a history of cancer who underwent jaw reconstruction was undertaken. Participants were identified from a database of jaw reconstruction procedures at the Chris O'Brien Lifehouse (Sydney, Australia). Eligible patients had at least one month follow-up, were aged ≥18 years at surgery, and had history of malignancy. HRQOL was measured using the FACE-Q Head and Neck Cancer Module (FACE-Q H&N). Functional outcomes were measured using the FACE-Q H&N, MD Anderson Dysphagia Inventory (MDADI) and Speech Handicap Index (SHI). Ninety-seven questionnaires were completed (62% response rate). Mean age of respondents was 63.7 years, 61% were male, and 64% underwent radiotherapy. Treatment with radiotherapy was associated with worse outcomes across 10/14 FACE-Q H&N scales, three MDADI subscales and one composite score, and the SHI. Mean differences in scores between irradiated and non-irradiated patients exceeded clinically meaningful differences for the MDADI and SHI. Issues with oral competence, saliva, speaking, and swallowing worsened with increasing time since surgery. Younger patients reported greater concerns with appearance, smiling, speaking, and cancer worry. Women reported greater concerns regarding appearance and associated distress. History of radiotherapy substantially impacts HRQOL and function after jaw reconstruction. Age at surgery and gender were also predictors of outcomes and associated distress. Pre-treatment counselling of patients requiring jaw reconstruction may lead to improved survivorship for patients with head and neck cancer.

Impact of targeted wording on response rates to a survey of general practitioners on referral processes for suspected head and neck cancer: an embedded randomised controlled trial.

Introduction Low response rates to surveys can lead to non-response bias, limiting generalisability of findings. When survey topics pertain to uncommon conditions, the decision of general practitioners (GPs) to complete a questionnaire may be swayed by the perceived relevance of the questionnaire content to their practice. Aim To explore whether targeted wording of a questionnaire for GPs about head and neck cancer referral patterns affects response rates. Methods A randomised controlled trial was embedded into a larger survey on referral practices for head and neck cancer among GPs in New South Wales, Australia. GPs were randomly allocated to receive versions of the study material with explanatory text written using either a 'symptom-frame' or a 'cancer-frame'; however, the questions and responses were the same in both groups. Results The overall response rate was 10.9% (196/1803). The response rate to the 'cancer-frame' version was 10.6% and 11.1% for the 'symptom-frame' version. After adjusting for practice location and GP gender, the difference in response rate based on wording was not significant (difference 0.5% [95%CI: -2.4, 3.4%]). A sub-analysis showed that GPs practicing in regional New South Wales were more likely to respond to the survey compared to those practicing in metropolitan New South Wales, independent of the intervention group or participant sex (AOR 1.61 [95%CI: 1.12, 2.31]; P = 0.01). Discussion The wording 'frame' of the survey did not appear to impact response rates in a survey of referral practices for suspected head and neck cancer; however, the significantly higher response rate from regional GPs warrants further investigation as to whether the content was considered more salient to their practice.

A qualitative exploration of the facilitators and barriers to early diagnosis and treatment of head and neck cancer: Perceptions of patients and carers.

OBJECTIVE: The objective of this study to explore experiences of patients and carers of the pathway to diagnosis and treatment of head and neck cancer (HNC), focusing on differences based on remoteness of residence. METHODS: Patients ≥6 months post-treatment completion, and their carers, were recruited. Semi-structured interviews, guided by the Model of Pathways to Treatment as the theoretical framework, were conducted to examine pathways to treatment of HNC and facilitators and barriers to early diagnosis and treatment. Thematic analysis with an iterative and data-driven approach was used to identify themes. RESULTS: A total of 39 patients and 17 carers participated in the interviews. Facilitators of timely diagnosis and treatment included a sense of urgency from health care professionals (HCPs), advocacy by the HCP or carers, and leveraging social capital. Distance to services, financial costs, and a perceived lack of emotional investment by HCPs arose as barriers to timely diagnosis and treatment. Participants were often able to rationalise that not all delays were negative, depending causes and expected impact on cancer management. CONCLUSION: The findings highlight the complex nature of factors facilitating and impeding early HNC diagnosis and treatment that may be targeted in interventions to support patients and meet important benchmarks for high-quality cancer care.

Geographic variation in referral practices for patients with suspected head and neck cancer: A survey of general practitioners using a clinical vignette.

INTRODUCTION: General practitioners (GPs) play a crucial role in cancer care and GPs are often the first doctor that patients with symptoms suggestive of cancer will encounter. Head and neck cancer (HNC) is a relatively uncommon presentation in primary care, and evidence suggests that times to diagnosis and treatment of HNC vary based on geographical location of patients. This may be due to barriers to referral faced by regional or rural GPs as compared to those in metropolitan cities in Australia. OBJECTIVE: To investigate the effect of geographical location of GPs on management of patients with symptoms suggestive of HNC. DESIGN: This was a descriptive, analytical, cross-sectional survey. Surveys were sent to GPs at practices in two primary health care networks in New South Wales, Australia (Mid North Coast Primary Healthcare Network and the Central and Eastern Sydney Primary Healthcare Network) between February and May 2020. Main outcome measures were perceived time from referral to specialist appointment, factors affecting timeliness of patient help-seeking, and awareness and use of clinical guidelines. FINDINGS: A total of 1803 GPs were sampled, of which 196 responded (45 regional GPs and 151 metropolitan GPs). Less than half (48%) of regional GPs reported patients could expect to be seen by a specialist within 2 weeks of referral, compared to 70% of metropolitan GPs (p = 0.001). Most metropolitan GPs stated they would refer a patient with suspected HNC to a surgeon subspecialising in HNC. Regional GPs were split between ear, nose, and throat (ENT) and general surgeons. Availability of services was the most common factor influencing referral practices for regional GPs, whereas for metropolitan GPs, this was the patient's symptoms. Awareness of government resources for cancer referrals was generally low. DISCUSSION: Regional GPs report patients with HNC are less likely to be seen by a specialist within optimal time frames compared to metropolitan GPs. Respondents reported different barriers to early referral of patients with suspected HNC, with regional GPs more often citing system-level factors while metropolitan GPs more often cited patient-level factors. CONCLUSION: Evaluating service provision and uptake with respect to community need, and addressing of barriers to implementation, may minimise unwarranted clinical variation.

Influence of remoteness of residence on timeliness of diagnosis and treatment of oral cavity and oropharynx cancer: A retrospective cohort study.

INTRODUCTION: Geographic disparities in head and neck cancer (HNC) outcomes in Australia may be mediated by timeliness of diagnosis and treatment. This retrospective cohort study examines geographic variations in survival and time intervals leading up to treatment for HNC at two tertiary referral centres in New South Wales. METHODS: Eligible patients were NSW residents aged ≥18 years, diagnosed with primary oropharynx or oral cavity squamous cell carcinoma (SCC) between 01 July 2008 and 30 June 2013, and treated with curative intent. Main outcomes were times from diagnosis to treatment and from surgery to post-operative radiotherapy and overall survival. Differences based on remoteness of residence (regional/remote or metropolitan) were assessed. RESULTS: A total of 224 patients were eligible. Median time from symptom onset to treatment was longer for regional/remote patients with oropharynx SCC (4.7 vs. 3.8 months, P = 0.044) and oral cavity SCC (6.4 vs. 3.3 months, P = 0.003). Median time from diagnosis to treatment was longer for regional/remote patients with oropharyngeal SCC (47 days vs. 36 days, P = 0.003). Time from surgery to adjuvant radiotherapy was longer among regional/remote patients with oral cavity SCC (66 vs. 42 days, P = 0.001). Overall survival did not differ based on remoteness. CONCLUSION: Regional/remote HNC patients experienced longer times to diagnosis and treatment, and regardless of remoteness of residence, fewer than half of patients were treated within guideline recommended timeframes. Despite this non-adherence to guidelines, there were no differences in survival outcomes among this cohort. However, the impact of not meeting guidelines on patient outcomes other than survival warrants further investigation.

Cross-Cultural Adaptation And Pilot Testing Of The Cancer Care Coordination Questionnaire For Patients (CCCQ-P) In Chinese And Arabic Languages.

BACKGROUND: The Cancer Care Coordination Questionnaire for Patients (CCCQ-P) has been designed to measure patients' experience of this crucial aspect of their cancer care. Migrants are at particular risk of receiving poorly coordinated cancer care due to challenges in communication as well as unfamiliarity with the health system and roles of health professionals. The aim of this study was to cross-culturally adapt and pilot test the CCCQ-P in Chinese and Arabic languages. METHODS: This study followed an established five-stage process for cross-cultural adaptation of self-report measures. The CCCQ-P was forward and back-translated into Arabic, Simplified Chinese, and Traditional Chinese languages by two independent translators. An expert committee review panel appraised the translations, resulting in a pre-final version in the target languages. Face validity, content validity, and consistency of the translated CCCQ-P were then assessed in a sample of bilingual former cancer patients and health professionals. In addition, structured interviews were conducted to explore the meaning of each question and responses to participants. RESULTS: Thirteen health professionals (7 Chinese, 6 Arabic) and 19 former cancer patients (11 Chinese, 8 Arabic) participated in the face validation. Across both language groups, participants agreed that the cross-culturally adapted and translated versions had clear instructions and response options that were appropriate and understandable. All items were considered important and significant to the tool and so no item was removed. Complex medical words caused some differences in preferred terminology in Arabic and Chinese; however, participants agreed that the meaning of the questions and response options was not lost. CONCLUSION: The Arabic, Simplified Chinese, and Traditional Chinese cross-culturally adapted and piloted versions of the CCCQ-P are useful tools to measure patients' experience of cancer care coordination. Further validation and psychometric testing of the instrument are warranted.

Comparing the effectiveness of general dietary advice versus a very low energy diet in an obese outpatient population in Australia.

PURPOSE: Obesity is a major public health burden. Outpatient clinics are an essential resource for individuals with obesity to access advice for weight loss management. The aim of this study was to compare anthropometric and weight loss outcomes between participants receiving general dietary (GD) advice, and those on a very low energy diet (VLED) under non-trial conditions. METHODS: Data from 276 adults with obesity attending a multidisciplinary weight management clinic were analysed. Changes in anthropometry, body composition, and blood pressure (BP) over 12 months were analysed using linear mixed-effects models. RESULTS: Males on the GD demonstrated statistically greater reductions in body weight (BW), BMI, percent fat mass (FM), systolic BP, waist and hip circumference (p < 0.01). Changes in males on a VLED did not reach significance. Females showed statistically significant reductions in BW, BMI, waist and hip circumference regardless of dietary intervention (p < 0.01); those on the GD significantly reduced percent FM (p < 0.001). Females on a VLED had statistically greater reductions in BW, BMI and systolic BP compared to those on the GD. No effect of exercise physiologist was observed in this study. Participants prescribed a GD attended for significantly longer than those on a VLED (p < 0.05), irrespective of gender. At 12 months, 14.3 and 4.5% of males and females on a VLED were still attending, compared to 10.6 and 4.5% on the GD. CONCLUSIONS: In this retrospective study, females in both dietary intervention groups achieved significant changes across multiple measures. Only men receiving GD advice demonstrated significant changes. LEVEL OF EVIDENCE: Level II-2.

School-Level Socioeconomic Status Influences Adolescents' Health-Related Lifestyle Behaviors and Intentions.

BACKGROUND: School-level socioeconomic status (SES) influences on adolescents' lifestyle behaviors is understudied. We examined how school-level SES and sex influence adolescents' health-related lifestyle behaviors and intentions. METHODS: Grade 8 students aged 13-14 years completed an online questionnaire regarding their sociodemographic characteristics, dietary behaviors, physical activity participation and recreational screen-time, and intentions regarding these behaviors. School-level SES, based on an Index of Community Socio-Educational Advantage (ICSEA), was categorized as low or high. Generalized estimating equations estimated individual-level summary statistics, adjusted for clustering. RESULTS: Students (N = 2538; response rate = 79%) from 23 high schools (low ICSEA = 16) participated. Compared with low ICSEA students, high ICSEA students were more likely to report eating breakfast daily (OR 1.9 [95% CI 1.5, 2.4]), not drinking sugar-sweetened beverages (SSBs) daily (2.9 [1.9, 4.3]), and were more likely to have intentions to eat breakfast (1.8 [1.3, 2.3]) and ≥ 5 vegetable serves (1.2 [1.0, 1.5]) daily. Boys were more likely than girls to meet recommendations for breakfast eating, vegetable intake, moderate-to-vigorous physical activity and screen-time, but boys were less likely to meet recommendations regarding SSB intake. CONCLUSIONS: Students from low ICSEA schools would benefit from additional support to improve dietary-related behaviors and intentions. More research is required to identify what targeted approaches will address sex differences in adolescents' lifestyle behaviors.

Critical Weight Loss in Patients With Oropharynx Cancer During Radiotherapy (± Chemotherapy).

Critical weight loss (CWL) defined as ≥5% in one month, is common in patients with oropharynx cancer and identification of patients at risk is challenging. We aimed to investigate if predictors of CWL in this population exist to guide nutritional intervention. Data were collected retrospectively on 134 patients who had radiotherapy (RT) ± concurrent chemotherapy (CRT) ± surgery. Body weights were collected pre-RT and during RT, with percentage weight change measured against baseline. Logistic regression was used to analyze chosen predictors. The incidence of CWL was 67% (26% of these patients experiencing ≥10% loss). Patients who had CRT experienced significantly higher weight loss (7.1% versus 4.7%; p = 0.001). Tube feeding was used in 64% of patients with CWL, the majority of tubes inserted reactively. These patients had a mean weight change of -8.8% (versus -7.1% in those with no tube) (p = 0.004). Multivariate models identified increased risk of CWL in tonsil origin tumors (p < 0.05), with CRT being the only predictor of weight loss ≥10% (p < 0.05). These patients are particularly vulnerable to CWL and the majority experience significant nutritional issues during RT, regardless of nutritional status at diagnosis. Nutritional intervention should be targeted accordingly.

A prospective patient-focused evaluation of the tolerance and acceptability of a stereotactic radiosurgery procedure.

Stereotactic radiosurgery (SRS) is a frequently used non-surgical procedure to treat benign and malignant brain lesions. Few studies have focused on patient perceptions of SRS. The aims of this patient-focused study were to assess patient experiences of SRS, and changes in patient-reported symptoms over 12weeks post-SRS. Using the 6-point Likert Scoring Scale in a diary-format for a less discriminatory evaluation, patients self-reported presence or absence, and severity of physical and psychological symptoms within 24h, 1-week, and 12-weeks post-SRS. Non-parametric repeated measures ANOVA was used to evaluate changes in symptoms. Of the 748 recruited patients, 690 returned the first diary (92%), while 564 patients returned all three diaries for matched responses analysis (82%). Three-quarters of 690 patients reported receiving clear verbal explanations and printed material prior to their procedure, and 99% reported the clinical team were 'very supportive' or gave 'wonderful care'. Fatigue (82%) and headaches (65%) were the most frequently reported symptoms within 24-h post-SRS. Over 12weeks, patients reported significant reductions in headache, nausea, fatigue, anxiety and tension (p<0.001); loss of balance and concentration significantly increased by 12-weeks post-SRS (p<0.001). Some patients attributed symptoms such as fatigue or headaches to the demands of the procedure day. Findings of this study reflect the need to further research patients' physical and psychological symptoms post-SRS, which may differ from the clinicians' perception of the effects of treatment.